FDA Law Blog

NOVEMBER 6, 2023

Admittedly, BiMo inspections (into items like adequacy of bioequivalence data, consistency of clinical trial data with medical records, and compliance with clinical trial protocols) lend themselves better to an RIE than assessing manufacturing compliance with regulatory requirements. We should explain what RIEs are.

Manufacturing 105

Manufacturing Clinic IT Utilities 105

FDA Law Blog

SEPTEMBER 17, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — Over the last three and a half years, meetings with FDA were conducted virtually. If you are driving, stop at the vehicle screening facility and inform security that you are attending a meeting. Getting to Building 66 Most CDRH meetings occur in Building 66.

Screening 59

Screening Transportation Provider Electronics 59

FDA Law Blog

JUNE 8, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic also deeply impacted how industry and the government conduct their operations. The pandemic also deeply impacted how industry and the government conduct their operations. However, not all changes are forever.

Relationship 53

Relationship Government Screening Medical 53

FDA Law Blog

NOVEMBER 2, 2023

These standards would be developed outside the Federal government, leveraging the expertise of the private sector. This program is modeled after a similar program in place for medical devices, the formal standards and conformity assessment program (S-CAP).

Provider 59

Provider Screening IT Government 59

FDA Law Blog

NOVEMBER 18, 2021

A positive result, however, is treated as a screen. That is just another way of saying, however, that the rapid antigen tests are best positioned as a screening tool. These tests could have been a valuable screening tool for COVID during the past year or so. A follow up laboratory?run run molecular diagnostic (RT?PCR)

Screening 98

Screening Healthcare Manufacturing IT 98

GeriPal

APRIL 18, 2024

I remember walking through San Francisco Airport with Bob, we just happened to be there at similar times, and saying, “Eric and I are thinking about starting a blog.” Then, it was like, well, it does as well as, and now, better than humans passing the medical boards, passing the law boards, doing great on the SAT, all that stuff.

IT 139

IT Electronics Patients Healthcare 139